PET and SPECT imaging systems are increasingly used for detection of diseases and are useful in providing early detection and a definite diagnosis for such diseases (e.g., disease states within oncology and neurology). For example, currently, a large percentage of PET and SPECT tests are related to cancer detection and early Alzheimer detection. These diseases require early diagnosis to allow a timely and effective treatment.
PET and SPECT imaging systems create images based on the distribution of positron-emitting isotopes and gamma emitting isotopes, respectively, in the tissue of a patient. The isotopes are typically administered to a patient by injection of radiopharmaceuticals including a probe molecule having a positron-emitting isotope, e.g., carbon-11, nitrogen-13, oxygen-15, or fluorine-18, or a gamma radiation emitting isotope, e.g. technetium-99. The radiopharmaceutical is readily metabolized, localized in the body or chemically binds to receptor sites within the body. Once the radiopharmaceutical localizes at the desired site (e.g., chemically binds to receptor sites), a PET or SPECT image is generated.
Examples of known radiopharmaceuticals include 18F-FLT ([18F]fluorothymidine), 18F-FDDNP (2-(1-{6-[(2-[18F]fluoroethyl)(methyl)amino]2-naphthyl}ethylidene)malonitrile), 18F-FHBG (9-[4-[18F]fluoro-3-(hydroxymethyl)butyl]guanine or [18F]-penciclovir), 18F-FESP ([18F]-fluoroethylspiperone), 18F-p-MPPF (4-(2-methoxyphenyl)-1-[2-(N-2-pyridinyl)-p-[18p]fluorobenzamido]ethylpiperazine) and 18F-FDG ([18F]-2-deoxy-2-fluoro-D-glucose). Radioactive isotopes in radiopharmaceuticals are isotopes exhibiting radioactive decay, for example, emitting positrons. Such isotopes are typically referred to as radioisotopes or radionuclides. Exemplary radioisotopes include 18F, 124I, 11C, 13N and 15O, which have half-lives of 110 minutes, 4.2 days, 20 minutes, 10 minutes, and 2 minutes, respectively.
Because radioisotopes have such short half-lives, the synthesis and purification of the corresponding radiopharmaceutical must be rapid and efficient. Any quality control (QC) assessments on the radiopharmaceutical must also take place in a short period of time.
Preferably, these processes (i.e., synthesis, purification, and QC assessment) should be completed in a time well under the half-life of the radioisotope in the radiopharmaceutical. Presently, QC assessments (e.g., chemical yield and chemical purity) may be relatively slow mainly due to the fact that they are conducted manually. Accordingly, there is a need for systems, components, and methods for capturing, analyzing, and interpreting data obtained during the synthesis and purification processes of a radiopharmaceutical to ensure that those synthesis and purification are proceeding efficiently to produce quality radiopharmaceuticals in a desired quantity. From this analysis, changes can be implemented before, during or after the synthesis and/or purification of the radiopharmaceutical to correct any deficiencies, as they occur during the radiopharmaceutical's synthesis. The embodiments of the present invention provide such systems, components, and methods, which allow for capture and analysis of real data, as well as the correction of deficiencies, during the synthesis of the radiopharmaceutical. A site to site comparison can also be performed to enable comparison across geographically diverse sites conducting radiopharmaceutical synthesis.